Injection needle — Class II medical device recall Z-2331-2025
Ongoing recall by Spiggle & Theis Mt Gmbh, reported 2025-08-27, distributed nationwide. Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of in
| Recall number | Z-2331-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spiggle & Theis Mt Gmbh, Dieburg, N/A, Germany |
| Recall initiated | 2025-06-27 |
| Classified | 2025-08-15 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04250381858806, 04250381858813 |
| Lot numbers | 2230438, 2240251 |
| Model numbers | 50-345-23, 50-353-23 |
Product
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
Reason for recall
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2331-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.